Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance
Primary Purpose
Hypertension, Impaired Glucose Tolerance
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
AR9281
AR9281
Placebo
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypertension focused on measuring hypertension, impaired glucose tolerance, s-EH enzyme inhibition, pre-diabetes
Eligibility Criteria
Inclusion Criteria:
- mild to moderate hypertension
- naive to antihypertensive medication or on two or less antihypertensive medications
- impaired glucose tolerance
- mild obesity
Exclusion Criteria:
- Diagnosis of Type 1 or Type 2 diabetes
- History of severe heart failure
- AST, ALT levels more than twice the normal range
Sites / Locations
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
- Arete Investigational site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Placebo Comparator
Arm Label
1
2
3
4
Arm Description
AR9281
AR9281
Placebo
Placebo
Outcomes
Primary Outcome Measures
Systolic and Diastolic blood pressure
Glucose dynamics and insulin sensitivity
Secondary Outcome Measures
Full Information
NCT ID
NCT00847899
First Posted
February 17, 2009
Last Updated
November 18, 2009
Sponsor
Arete Therapeutics
1. Study Identification
Unique Protocol Identification Number
NCT00847899
Brief Title
Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance
Official Title
A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging, Exploratory, 28-Day Study to Examine the Effects of AR9281 on Blood Pressure and Glucose Tolerance in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance
Study Type
Interventional
2. Study Status
Record Verification Date
November 2009
Overall Recruitment Status
Completed
Study Start Date
January 2009 (undefined)
Primary Completion Date
October 2009 (Actual)
Study Completion Date
November 2009 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Arete Therapeutics
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is to determine the safety and efficacy of AR9281, a novel s-EH enzyme inhibitor, in improving glucose metabolism and blood pressure in patients with impaired glucose tolerance and mild to moderate hypertension.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Impaired Glucose Tolerance
Keywords
hypertension, impaired glucose tolerance, s-EH enzyme inhibition, pre-diabetes
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
150 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Active Comparator
Arm Description
AR9281
Arm Title
2
Arm Type
Active Comparator
Arm Description
AR9281
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Placebo
Arm Title
4
Arm Type
Placebo Comparator
Arm Description
Placebo
Intervention Type
Drug
Intervention Name(s)
AR9281
Intervention Description
AR9281 taken in BID dosing regimen for 28 days
Intervention Type
Drug
Intervention Name(s)
AR9281
Intervention Description
AR9281 taken in TID dosing regimen for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo taken in BID dosing regimen for 28 days
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo taken in TID dosing regimen for 28 days
Primary Outcome Measure Information:
Title
Systolic and Diastolic blood pressure
Time Frame
28 day treatment period
Title
Glucose dynamics and insulin sensitivity
Time Frame
28 day treatment period
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
mild to moderate hypertension
naive to antihypertensive medication or on two or less antihypertensive medications
impaired glucose tolerance
mild obesity
Exclusion Criteria:
Diagnosis of Type 1 or Type 2 diabetes
History of severe heart failure
AST, ALT levels more than twice the normal range
Facility Information:
Facility Name
Arete Investigational site
City
Mobile
State/Province
Alabama
ZIP/Postal Code
36617
Country
United States
Facility Name
Arete Investigational site
City
Muscle Shoals
State/Province
Alabama
ZIP/Postal Code
35662
Country
United States
Facility Name
Arete Investigational site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Arete Investigational site
City
Concord
State/Province
California
ZIP/Postal Code
94520
Country
United States
Facility Name
Arete Investigational site
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Arete Investigational site
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34203
Country
United States
Facility Name
Arete Investigational site
City
Deland
State/Province
Florida
ZIP/Postal Code
32720
Country
United States
Facility Name
Arete Investigational site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32216
Country
United States
Facility Name
Arete Investigational site
City
Largo
State/Province
Florida
ZIP/Postal Code
33770
Country
United States
Facility Name
Arete Investigational site
City
Miami
State/Province
Florida
ZIP/Postal Code
33169
Country
United States
Facility Name
Arete Investigational site
City
New Port Richey
State/Province
Florida
ZIP/Postal Code
34652
Country
United States
Facility Name
Arete Investigational site
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33026
Country
United States
Facility Name
Arete Investigational site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Facility Name
Arete Investigational site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Arete Investigational site
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30066
Country
United States
Facility Name
Arete Investigational site
City
Addison
State/Province
Illinois
ZIP/Postal Code
60101
Country
United States
Facility Name
Arete Investigational site
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40213
Country
United States
Facility Name
Arete Investigational site
City
Brockton
State/Province
Massachusetts
ZIP/Postal Code
02301
Country
United States
Facility Name
Arete Investigational site
City
Paw Paw
State/Province
Michigan
ZIP/Postal Code
49079
Country
United States
Facility Name
Arete Investigational site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89123
Country
United States
Facility Name
Arete Investigational site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Arete Investigational site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45245
Country
United States
Facility Name
Arete Investigational site
City
Marion
State/Province
Ohio
ZIP/Postal Code
43302
Country
United States
Facility Name
Arete investigational site
City
Mt. Gilead
State/Province
Ohio
ZIP/Postal Code
43338
Country
United States
Facility Name
Arete Investigational site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73132
Country
United States
Facility Name
Arete Investigational site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97404
Country
United States
Facility Name
Arete Investigational site
City
Austin
State/Province
Texas
ZIP/Postal Code
78704
Country
United States
Facility Name
Arete Investigational site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75251
Country
United States
Facility Name
Arete Investigational site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Arete Investigational site
City
Orem
State/Province
Utah
ZIP/Postal Code
84058
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.aretetherapeutics.com
Description
Arete Therapeutics home website
Learn more about this trial
Evaluation of Soluble Epoxide Hydrolase (s-EH) Inhibitor in Patients With Mild to Moderate Hypertension and Impaired Glucose Tolerance
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